Post-Market Surveillance, referred to in English terminology as Post-Market Surveillance and abbreviated as PMS, denotes the entirety of all activities by which a manufacturer, after placing a product on the market, systematically collects and evaluates data on the quality, performance and safety of its products. Article 83 of Regulation (EU) 2017/745 requires manufacturers to plan, establish, document, implement, maintain and keep up to date such a system for each product, in a manner that is proportionate to the risk class and the nature of the product. The system is explicitly an integral part of the quality management system under Article 10(9) and is therefore not a separate post-market follow-up project. This entry addresses the obligation to have a system; the reporting formats by risk class are covered in the entry EU MDR 2017/745, and the planning document in the entry Post-Market Surveillance Plan under the MDR.
Legal definition and scope of the system obligation
Under Article 83(2), the system must be suitable to actively and systematically collect, record and analyse relevant data throughout the entire lifetime of a product, draw the necessary conclusions from it, and identify, implement and monitor preventive and corrective actions. The three verbs collect, analyse and act together describe the minimum scope: collecting without evaluation does not meet the requirement, nor does evaluation without documented consequences.
The proportionality clause only permits adapting scope, frequency and methodology, not dispensing with a system. The lifetime linkage must also be taken literally: as long as products are in the field, the surveillance obligation does not end when production ends.
Proactive and reactive data sources
Reactive sources are events that reach the manufacturer from outside: complaints, feedback from users, distributors and importers, reports of suspected incidents, returns and service reports. Proactive sources are generated by the manufacturer itself or are systematically accessed, for example through user surveys, systematic literature and database searches, registries, the evaluation of publicly available information on similar products, and through clinical follow-up, as described in the entry Post-Market Clinical Follow-up.
A robust system uses both sides and relates metrics to sales volumes so that frequencies remain interpretable.
Use of the results
Article 83(3) sets out exhaustively what the data obtained are to be used for: updating the benefit-risk determination and improving risk management; updating design, manufacturing information, instructions for use and labelling; updating the clinical evaluation and the summary of safety and clinical performance; determining the need for preventive, corrective or field safety corrective actions; improving usability, performance and safety; where appropriate, contributing to the surveillance of other products; and detecting and reporting trends under Article 88. The technical documentation must be updated accordingly.
Post-Market Surveillance is therefore a closed-loop process with feedback into the conformity evidence. If a need for action is identified, Article 83(4) requires appropriate measures as well as informing the competent authorities and, where applicable, the notified body.
Relationship to trend reporting and reporting obligations
Trend reporting under Article 88 is the statistical arm of Post-Market Surveillance: any statistically significant increase in the frequency or severity of non-serious incidents or expected undesirable side effects must be reported if this could significantly affect the benefit-risk analysis. Methodology, comparator baseline and observation period must be defined in advance for this purpose. Depending on the class, the evaluation results in a report under Article 85 or a periodically updated safety report under Article 86.
Distinction from regulatory market surveillance
Post-Market Surveillance is a manufacturer obligation; market surveillance is a task of the authorities. Under Article 93, the competent authorities verify, on the basis of appropriate samples, the conformity of product characteristics and performance, review documentation, carry out physical checks and laboratory tests, and take vigilance data and complaints into account. They draw up annual plans, conduct announced and, where necessary, unannounced inspections at economic operators, suppliers and subcontractors, and publish annual summaries in the designated electronic system.
A manufacturer’s own Post-Market Surveillance does not replace regulatory review and, conversely, is a key subject of inspections and audits. Vigilance in the narrower sense must also be distinguished: it covers only the stream of reportable events, whereas Post-Market Surveillance also evaluates unremarkable data.
Relevance for clinical trials
Post-Market Surveillance and clinical evidence are permanently linked under Regulation (EU) 2017/745. Findings from the field feed into updates of the clinical evaluation and may show that the available evidence is insufficient for certain indications, patient groups or use environments. This gap gives rise to study questions that are translated into clinical follow-up with defined endpoints and an analysis plan.
Conversely, ongoing studies provide data that must feed back into Post-Market Surveillance. Full-service CROs such as Mediconomics support manufacturers in collecting surveillance data and study data in a methodologically aligned manner, assessing signals consistently, and translating the results into reporting formats that notified bodies and authorities can understand and verify.
Frequently Asked Questions (FAQ)
Does the Post-Market Surveillance obligation also apply to Class I products?
Yes. Article 83 applies to all products. Manufacturers of Class I products prepare, instead of a safety report, a post-market surveillance report under Article 85 and make it available to the competent authority upon request.
Is Post-Market Surveillance the same as vigilance?
No. Vigilance covers the reporting of serious incidents and field safety corrective actions. Post-Market Surveillance is the broader process that also includes non-reportable data, literature, registries and user feedback.
Who within the company is responsible for the system?
Responsibility lies with the manufacturer. Under Article 15, the person responsible for regulatory compliance must ensure that the post-market surveillance obligations and the reporting obligations under Articles 87 to 91 are fulfilled.
Regulatory References
- Regulation (EU) 2017/745, Article 83 — Manufacturer’s post-market surveillance system
- Regulation (EU) 2017/745, Articles 85 and 86 — Post-market surveillance report and periodic safety update report
- Regulation (EU) 2017/745, Article 88 — Trend reporting
- Regulation (EU) 2017/745, Article 93 — Market surveillance activities of the competent authorities
- Regulation (EU) 2017/745, Annex III — Technical documentation on post-market surveillance
